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October 22/29, 2003

Local vs Central Institutional Review Boards for Multicenter Studies

Author Affiliations

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2003;290(16):2126-2127. doi:10.1001/jama.290.16.2126-a

In Reply: Although we appreciate Dr Rosé's argument for diversity, we contend that there is a point of diminishing returns when diverse and redundant review interferes with uniform participant protection. For instance, 23% of local IRBs deemed the same protocol to be eligible for expedited review, while the others did not. This variability reveals serious differences in the review process, not simply diversity. Differences in the review process can manifest in several ways. For example, revisions mandated by the different language requirements of local IRBs could have produced consent forms that did not articulate the intended study protocol. Thus, we remain concerned that the current system does not ensure equal protection of the rights and welfare of human participants in large multicenter studies.